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The Efficacy and Safety of Neoadjuvant Therapy With Iparomlimab and Tuvonralimab in Locally Advanced MSI-H/dMMR Colorectal Cancer: An Prospective, Single-Arm Study (Neo-IT)

NCT07160647 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2025-12-02

No results posted yet for this study

Summary

Immunotherapy may bring revolutionary changes to the preoperative neoadjuvant treatment mode for dMMR/MSI-H locally advanced rectal cancer. According to the existing theory, the use of Iparomlimab and Tuvonralimab may be the best solution. In this study, the investigators will perform single-cell sequencing of participants tissue samples, fully explore the multi-dimensional omics information of tumors and microenvironments, explore the characteristics of the treatment benefit population, and try to construct an efficacy prediction model to screen the treatment benefit population early and implement precise treatment.

Conditions

  • dMMR/MSI-H-type Rectal Adenocarcinoma

Interventions

DRUG

Ipalolimab and Tovorilimab

1.Active Ingredients: Ipalolimab and Tovorilimab (a dual-functional combination antibody consisting of Ipalolimab, a recombinant humanized monoclonal antibody targeting programmed death receptor-1 \[PD-1\], and Tovorilimab, a recombinant humanized monoclonal antibody targeting cytotoxic T-lymphocyte-associated protein-4 \[CTLA-4\]). 2.Specification: 50 mg (2 mL) per vial. 3.Dosage and Administration: Administer via intravenous infusion at a recommended dose of 5 mg/kg every 3 weeks.

Sponsors & Collaborators

  • Sir Run Run Shaw Hospital

    lead OTHER

Principal Investigators

  • Xiujun Cai, MD · Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang 310016

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-20
Primary Completion
2027-08-30
Completion
2030-08-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07160647 on ClinicalTrials.gov